BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2042379 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02396
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) REVIEWED A SAVE TO DISK, AND DISCUSSED THAT BASED ON THE AVAILABLE INFORMATION AND ANALYSIS RESULTS, THE DEVICE FUNCTIONED NORMALLY AS PROGRAMMED AND AS DESIGNED. HOWEVER, THERAPY FOR TRUE VT WAS DELAYED BECAUSE OF LIMITATIONS OF THE DETECTION ALGORITHM TO SENSE CONSECUTIVE LARGE VARIATIONS IN INTRINSIC R WAVE AMPLITUDE. SEVERAL NONSUSTAINED EPISODES WERE ALSO OBSERVED. BSC TS THEN DISCUSSED TROUBLESHOOTING METHODS ON HOW TO AVOID UNDERSENSING OF ALTERNATING AMPLITUDES IN THE FUTURE. BSC TS ALSO DISCUSSED THAT THE ELECTROGRAM HAD NO CALIBRATION, WHICH MEANS THE INTRINSIC AMPLITUDE FOR EACH COMPLEX WAS UNKNOWN. INTRINSIC AMPLITUDE MEASUREMENTS AND DAILY MEASUREMENTS CAN BE A REFERENCE, HOWEVER, IN THIS CASE OF ALTERNATING AMPLITUDES, ONE DOESN'T KNOW WHETHER HIGH OR LOW AMPLITUDES ARE SHOWN IN THE RESULTS. BSC TS MENTIONED THAT PROGRAMMING RV SENSITIVITY TO MOST, AS THE PHYSICIAN DID, WAS THE BEST OPTION. THIS ICD REMAINS IN SERVICE, AND NO CHANGES HAVE BEEN MADE AT THIS TIME. THIS ICD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING. IT WAS OBSERVED DURING ONE EPISODE THAT EVERY ONE OF TWO BEATS WAS UNDERSENSED DURING DETECTION IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. THIS RESULTED IN THERAPY DIVERTING DURING CHARGING DUE TO NOT MEETING DETECTION REQUIREMENTS, AND PATIENT REMAINED IN VT. SHOCK THERAPY WAS THEN DELIVERED DURING THE SECOND EPISODE, BUT IT WAS NOTED THAT DELIVERY TOOK LONGER THAN NORMAL. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1